Uses

What is Dulera® inhaler (formoterol and mometasone) used for?

Dulera® inhaler contains a combination of formoterol and mometasone. Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing. Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Dulera® inhaler is used as a maintenance treatment for asthma in adults and children who are at least 12 years old. Dulera® inhaler is not for use in treating an asthma or bronchospasm attack.

Dulera® inhaler may also be used for purposes not listed in this medication guide.

How should I take Dulera® inhaler (formoterol and mometasone)?

Dulera® inhaler comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Formoterol may increase the risk of asthma-related death. Use only the prescribed dose of Dulera® inhaler, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using Dulera® inhaler.

Dulera® inhaler will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Shake the Dulera® inhaler canister well before each use. Remove the cap from the mouthpiece before placing the inhaler in your mouth.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using the inhaler. Do not swallow.

It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.

If you need surgery, tell the surgeon ahead of time that you are using Dulera® inhaler.

If you also use a steroid medication, you should not stop using Dulera® inhaler suddenly. Follow your doctor’s instructions about tapering your dose.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

How do I store Dulera® inhaler (formoterol and mometasone)?

Dulera® inhaler is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Dulera® inhaler in the bathroom or the freezer. There may be different brands of Dulera® inhaler that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Dulera® inhaler down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Dulera® inhaler (formoterol and mometasone)?

Before using this drug, tell your doctor if:

You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.

You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.

You have allergy with any of active or inactive ingredients of Dulera® inhaler or other medications.

You have any other illnesses, disorders, or medical conditions.

You should not use Dulera® inhaler if you are allergic to formoterol (Foradil, Perforomist, Symbicort) or mometasone (Asmanex).

To make sure Dulera® inhaler is safe for you, tell your doctor if you have:

A history of aneurysm (a weakened or damaged blood vessel that could tear and cause severe bleeding)

Do not give Dulera® inhaler to a child younger than 12 years old without the advice of a doctor.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Dulera® inhaler during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Dulera® inhaler. Dulera® inhaler is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

A=No risk

B=No risk in some studies

C=There may be some risk

D=Positive evidence of risk

X=Contraindicated

N=Unknown

Side effects

What side effects can occur from Dulera® inhaler (formoterol and mometasone)?

Get emergency medical help if you have any signs of an allergic reaction to Dulera® inhaler: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

Sores or white patches in your mouth or throat

Wheezing, choking, or other breathing problems after using this medication

Blurred vision, eye pain, or seeing halos around lights

Changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist)

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Dulera® inhaler (formoterol and mometasone)?

Dulera® inhaler may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Dulera® inhaler (formoterol and mometasone)?

Dulera® inhaler may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Dulera® inhaler (formoterol and mometasone)?

Dulera® inhaler may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Dulera® inhaler (formoterol and mometasone).

What is the dose of Dulera® inhaler (formoterol and mometasone) for an adult?

Usual Adult Dose for Asthma – Maintenance:

The recommended starting dosages for formoterol-mometasone treatment are based on prior asthma therapy.

Formoterol-mometasone should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route. Shake well prior to each inhalation.

How is Dulera® inhaler (formoterol and mometasone) available?

Dulera® inhaler is available in the following dosage forms and strengths:

Aerosol: mometasone furoate 100ug, formoterol fumarate 5ug

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Dulera® inhaler, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.